Senior / Lead CQV Engineer

Roles & Responsibilities

About the Role :

We invite highly motivated individuals to join our team in providing support to our clients’ biomanufacturing facilities. In this role, you will be tasked with performing pre-commissioning checks and detailed testing, troubleshooting process / equipment issues, preparing comprehensive reports, collaborating with cross-functional teams, and ensuring strict adherence to pharmaceutical GMP and regulatory standards.

Key Responsibilities :

• Execution : Plan and execute CQV activities for biomanufacturing facilities, utilities (like WFI or HVAC), and bioprocess equipment.
• Compliance : Ensure all activities and documentation meet GMP, regulatory requirements and company procedures.
• Coordination : Work with engineering, project, quality, and vendor teams to coordinate and execute CQV activities.
• Troubleshooting : Identify and resolve issues encountered during the commissioning and qualification process.
• Documentation : Develop and review Commissioning, Qualification, and Validation (CQV) lifecycle documentation , including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) , and Performance Qualification (PQ) .

Requirements :

Tell employers what skills you have

DCS

Troubleshooting

Fermentation

GMP

Project Quality

Cell Culture

Bioprocess

Unit Operations

Compliance

Plant Operations

Manufacturing